Postherpetic Neuralgia ( PHN )Phase 2NCT07758920
A Clinical Trial to Evaluate the Efficacy and Safety of HL-1186 Tablet in the Treatment of Postherpetic Neuralgia
A Phase 2 study testing HL-1186 and Pregabalin capsule in people with Postherpetic Neuralgia ( PHN ), run by Shanghai Yidian Pharmaceutical Technology Development Co., Ltd. at 1 site in China.
Trial summary
This is a multicenter, randomized, double-blind, double-dummy, placebo- and active-controlled, parallel-group trial to evaluate the safety, efficacy and pharmacokinetic (PK) profile of HL-1186 Tablet in patients with postherpetic neuralgia (PHN). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postherpetic Neuralgia ( PHN )
- What is being tested?
- HL-1186 and Pregabalin capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Aug 2026to Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 18 years, of either sex.
- Pain persists for 1 month or more after healing of skin lesions in patients with herpes zoster.
- Participants fully understand the purpose, characteristics, methods of the trial and possible AEs, voluntarily participate in the trial and sign the ICF, or have their legal guardian sign the ICF on their behalf.
Who cannot join
- Participants with any pain other than PHN, or with other diseases that the researcher considers to potentially affect the evaluation of PHN.
- Participants who may be allergic to the active ingredients or excipients of HL-1186 Tablet, HL-1186 Tablet placebo, pregabalin capsule or pregabalin capsule placebo, have an allergic constitution, or have a history of allergies to ≥ 3 substances.
- Participants who have used drugs that may damage nerves (such as tumor chemotherapy drugs) after being diagnosed with PHN.
- The baseline NRS collection begins within the 5 half-lives following the last use of the prohibited drug.
- Participants who have previously used pregabalin with inadequate efficacy or intolerance.
- Clinically significant abnormalities in the 12-lead electrocardiogram (ECG) during the screening period, or complicated with severe cardiopulmonary diseases, which are deemed unsuitable for inclusion by the researcher.
Show all 12Show fewer
- Participants with a history of malignant tumors within 2 years prior to screening.
- Participants who have undergone major surgery within 8 weeks prior to enrollment or plan to undergo any surgery during the trial period.
- Participants with positive human immunodeficiency virus antibody, positive syphilis serological test, positive hepatitis B virus surface antigen with hepatitis B virus DNA > ULN, or positive hepatitis C virus antibody with hepatitis C virus RNA > ULN.
- Participants with a history of alcoholism or drug abuse within 2 years before screening.
- Female participants who are pregnant, breastfeeding (within 1 year after delivery), or with a positive pregnancy test.
- Participants deemed by the investigator to be unsuitable for participating in this trial for any reason.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This is a multicenter, randomized, double-blind, double-dummy, placebo- and active-controlled, parallel-group trial to evaluate the safety, efficacy and pharmacokinetic (PK) profile of HL-1186 Tablet in patients with postherpetic neuralgia (PHN).
- Conditions
- Postherpetic Neuralgia ( PHN )
- Being tested
- HL-1186, HL-1186 placebo, Pregabalin capsule, Pregabalin capsule placebo
- Medical subject headings
- Neuralgia, Postherpetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HL-1186Drug
HL-1186 tablet for oral administration
HL-1186 placeboDrug
HL-1186 placebo tablet for oral administration
Pregabalin capsuleDrug
Pregabalin capsule for oral administration
Pregabalin capsule placeboDrug
Pregabalin capsule placebo for oral administration
| Study group | Role | What they receive |
|---|---|---|
| HL-1186 High Dose | Experimental | Participants will receive continuous HL-1186 administration for 12 weeks Receives: Drug: HL-1186; Drug: Pregabalin capsule placebo |
| HL-1186 Medium Dose | Experimental | Participants will receive continuous HL-1186 administration for 12 weeks Receives: Drug: HL-1186; Drug: HL-1186 placebo; Drug: Pregabalin capsule placebo |
| HL-1186 Low Dose | Experimental | Participants will receive continuous HL-1186 administration for 12 weeks Receives: Drug: HL-1186; Drug: HL-1186 placebo; Drug: Pregabalin capsule placebo |
| Pregabalin | Active comparator | Participants will receive continuous Pregabalin administration for 12 weeks Receives: Drug: HL-1186 placebo; Drug: Pregabalin capsule |
| Placebo | Placebo comparator | Participants will receive continuous placebo administration for 12 weeks Receives: Drug: HL-1186 placebo; Drug: Pregabalin capsule placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Average Daily Pain Score (ADPS) from baseline after 12 weeks of administration
ADPS = sum of NRS scores within 7 days / number of times the form is filled out NRS (Numeric Rating Scale, 0 =no pain to 10 =worst possible pain)
Measured: Day 1 to Day 84
Secondary outcomes (1)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: Day 1 to Day 98
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postherpetic Neuralgia ( PHN )Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07758920
- Sponsor's protocol ID
- PY-HL-1186-PHN-304
- Status last verified
- Aug 2026
- First submitted
- 2 Aug 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Evaluate the Efficacy and Safety of HL-1186 Tablet in the Treatment of Postherpetic Neuralgia
- ClinicalTrials.gov ID
- NCT07758920
- Acronym / sponsor ID
- PY-HL-1186-PHN-304
- Conditions
- Postherpetic Neuralgia ( PHN )
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, randomized, double-blind, double-dummy, placebo- and active-controlled, parallel-group trial to evaluate the safety, efficacy and pharmacokinetic (PK) profile of HL-1186 Tablet in patients with postherpetic neuralgia (PHN).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| HL-1186 High Dose | Experimental | Drug: HL-1186, Drug: Pregabalin capsule placeboParticipants will receive continuous HL-1186 administration for 12 weeks |
| HL-1186 Medium Dose | Experimental | Drug: HL-1186, Drug: HL-1186 placebo, Drug: Pregabalin capsule placeboParticipants will receive continuous HL-1186 administration for 12 weeks |
| HL-1186 Low Dose | Experimental | Drug: HL-1186, Drug: HL-1186 placebo, Drug: Pregabalin capsule placeboParticipants will receive continuous HL-1186 administration for 12 weeks |
| Pregabalin | Active comparator | Drug: HL-1186 placebo, Drug: Pregabalin capsuleParticipants will receive continuous Pregabalin administration for 12 weeks |
| Placebo | Placebo comparator | Drug: HL-1186 placebo, Drug: Pregabalin capsule placeboParticipants will receive continuous placebo administration for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged ≥ 18 years, of either sex.
- Pain persists for 1 month or more after healing of skin lesions in patients with herpes zoster.
- Participants fully understand the purpose, characteristics, methods of the trial and possible AEs, voluntarily participate in the trial and sign the ICF, or have their legal guardian sign the ICF on their behalf.
Key exclusion criteria (12 listed)
- Participants with any pain other than PHN, or with other diseases that the researcher considers to potentially affect the evaluation of PHN.
- Participants who may be allergic to the active ingredients or excipients of HL-1186 Tablet, HL-1186 Tablet placebo, pregabalin capsule or pregabalin capsule placebo, have an allergic constitution, or have a history of allergies to ≥ 3 substances.
- Participants who have used drugs that may damage nerves (such as tumor chemotherapy drugs) after being diagnosed with PHN.
- The baseline NRS collection begins within the 5 half-lives following the last use of the prohibited drug.
- Participants who have previously used pregabalin with inadequate efficacy or intolerance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HL-1186HL-1186 tablet for oral administration | Drug | HL-1186 High Dose, HL-1186 Low Dose, HL-1186 Medium Dose |
| HL-1186 placeboHL-1186 placebo tablet for oral administration | Drug | HL-1186 Low Dose, HL-1186 Medium Dose, Placebo, Pregabalin |
| Pregabalin capsulePregabalin capsule for oral administration | Drug | Pregabalin |
| Pregabalin capsule placeboPregabalin capsule placebo for oral administration | Drug | HL-1186 High Dose, HL-1186 Low Dose, HL-1186 Medium Dose, Placebo |
Primary outcome
Change in the Average Daily Pain Score (ADPS) from baseline after 12 weeks of administration
Time frame: Day 1 to Day 84
ADPS = sum of NRS scores within 7 days / number of times the form is filled out NRS (Numeric Rating Scale, 0 =no pain to 10 =worst possible pain)
1 secondary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Day 1 to Day 98
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Postherpetic Neuralgia ( PHN )
Not yet recruitingPhase 1
Simultaneous Engagement of Networks for Alleviating Pain (SENAP)
Neuropathic Pain, Postherpetic Neuralgia
Active, not recruiting
Transcranial Magnetic Stimulation for Chronic Neuropathic Pain
Chronic Neuropathic Pain, Post-Stroke Pain
Active, not recruitingObservational study
Obesity and Obesity-Related Factors and Risk of Herpes Zoster (Shingles) and Postherpetic Neuralgia
Herpes Zoster (HZ)
Recruiting
The Analgesic Efficacy and Safety of Venlafaxine for Prevention of Postherpetic Neuralgia in Patients With Acute Herpes Zoster
Herpes Zoster, Pain
Not yet recruiting
Efficacy and Safety of Intravenous Dexamethasone Palmitate Treatments in Acute and Subacute Herpes Zoster Pain
Herpes Zoster Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HL-1186 and Pregabalin capsule in people with Postherpetic Neuralgia ( PHN ), run by Shanghai Yidian Pharmaceutical Technology Development Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Renhai Yang (021-64311017, clinical_trial@hllife.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Average Daily Pain Score (ADPS) from baseline after 12 weeks of administration (time frame: Day 1 to Day 84). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.